Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan’s First Humira Biosimilar Could Hit Market as Early as November
AbbVie/Eisai’s anti-TNF-α monoclonal antibody Humira (adalimumab) could face biosimilar competition as early as November, as the Japanese health ministry is scheduled to report late this month its plan to approve its first follow-on version filed by Fujifilm Kyowa Kirin Biologics.…
To read the full story
Related Article
- Fujifilm Kyowa Kirin, Mylan Bag EU Approval of Humira Biosimilar
September 25, 2018
- Humira Biosimilar Grabs European Panel Backing: Fujifilm Kyowa Kirin/Mylan
July 31, 2018
- Mylan Gets EU Rights for Fujifilm Kyowa Kirin Biologics’ Humira Biosimilar
April 12, 2018
- EMA Accepts Application for Fujifilm Kyowa Kirin’s Humira Biosimilar
May 23, 2017
REGULATORY
- Japan OKs Coverage for Susmed Insomnia App, Shionogi ADHD Therapy App
May 15, 2026
- MHLW’s Mori Vows to Make Japan Pharma Market “More Attractive”
May 15, 2026
- MHLW Official Says US MFN Policy Could Be Taken Up by Chuikyo
May 15, 2026
- Oncolys’ Telomelysin Up for Japan Panel Review on May 21
May 15, 2026
- Japan to Launch CEA “Technical Discussions” under MHLW Research Group
May 14, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…